Four Steps to Help Sponsors and CROs adopt eConsent
Despite a growing interest in eConsent among sponsors and CROs, there is still much hesitation about abandoning the traditional paper-based process. If you are tasked with implementing eConsent in an upcoming trial this article lays out some important steps that should make the process easier for you and your organization.
There is a growing recognition of the advantages of eConsent in the clinical trials industry. As technology is increasingly used to facilitate health care and clinical trials the broad shift to eConsent for trials appears inevitable. Many companies have plans to pilot or test the technology in future studies.
However, the decision to try eConsent is not made lightly, nor should it be. Before eConsent can be embraced, sponsors and CROs need to understand how legal and regulatory requirements related to consent would apply to an electronic approach. eConsent vendors must be vetted with audits and selection processes. And finally, costs must be understood; the cost of the product itself, and the time and resources to deploy it (which is much harder to quantify).
Step 1: Read the FDA Draft Guidance on Electronic Consent
Start by reading FDA’s draft guidance Use of Electronic Informed Consent in Clinical Investigations. If you are unfamiliar with eConsent this will give you the orientation you need to understand the landscape. Even if you have some exposure to eConsent in trials, it is wise to read up on the FDA’s expectations.
The draft guidance gives clarity around how to implement electronic consent for clinical trials. It includes requirements and considerations that will help you to identify an appropriate vendor and ensure that their product meets the regulatory requirements. It also outlines the responsibilities of the IRB and expectations for the process of consent when using eConsent, which will help facilitate discussions with sites and the IRB. A few key points from the document are outlined below.
What are the FDA’s key points about eConsent?
- Electronic signatures must be compliant with FDA regulations—specifically 21 CFR Part 11
- A copy of the consent must be given but can be electronic
- IRBs must review and approve the electronic consent and any amendments
- The eConsent must be submitted for FDA approval for IDE studies (as with paper ICFs) and may be required for IND studies in certain circumstances
- During FDA inspection, FDA will require site-specific versions of the eConsent, materials submitted to the IRBs for review and approval, all amendments to the site-specific eConsents, and all subject-signed eConsents. Any updates to this documentation should also be available; these can be available either in electronic of paper form.
Step 2: Take the IRB’s Pulse on eConsent
It is important to know what the Institutional Review Board will require in order to review and approve the use of eConsent in a trial. Reach out to all the independent IRBs you usually work with to determine their requirements. Many of the major independent IRBs have probably had some exposure to eConsent; however, local IRBs may not have seen the technology yet. Questions about local IRB requirements could be incorporated into the site selection process to ensure that you know what to expect when trying to get sites up and running. Some important questions for IRBs are outlined below.
Questions for IRBs
- What is your review process for eConsent?
- Does the IRB have any concerns or considerations regarding eConsent that we should be aware of?
- Can you provide an example of the approval documentation for eConsent?
- What documentation or explanation will you require to understand how the eConsent software/system/product works?
- What specific information do you require about system security?
Step 3: Questions for your eConsent Vendor about Documentation, Training, and Support
When evaluating an eConsent vendor the system requirements will be similar to those of any vendor that handles subject and trial data. However, given the technology as a whole is new, look closely at the support the vendor offers leading up to and during the trial. Especially consider whether they offer assistance with implementation and education of various stakeholders (such as the IRB and site personnel).
What should I consider when evaluating eConsent vendors?
- Documentation: Documentation considerations are different when it comes to certain eConsent products. For example, with an eConsent product that is used through an application (or app) how will the vendor provide appropriate documentation to the IRB, sites and the sponsor that can be viewed on devices that may not have access to the application . In addition to providing the actual app, what other reports, or documents will be provided as a part of the service. Refer back to the FDA Draft Guidance on eConsent to make sure they can provide what you would need in the event of an audit.
- Training & Demonstrations: At this stage you are likely to encounter individuals that have never seen eConsent in a clinical trial, such as IRB members or site personnel. Training and demonstrations are important to give these individuals an understanding of the technology and, in the case of site or sponsor personnel, make sure they utilize it properly. A vendor should be able to support or provide training for personnel at the sponsor, CRO, and sites as well as provide reviewing IRBs with a demonstration or documentation to satisfy their requirements and give them an understanding of how the technology works.
- Tech Support: In addition to training, the vendor should also be able to provide support with any technical issues that occur during the course of the trial. Adopting eConsent for a trial will require additional time and resources that are not well spent if technology issues or questions about the product interfere with the consent process at the site.
Step 4: Develop Expectations and a Fallback for eConsent
Be prepared for bumps in the road when planning for eConsent. Consider how you can assign resources to make sure that any issues are tracked and resolved quickly. Make sure you have a fallback paper-based consent approved for each site (and keep it updated with each amendment) if the eConsent cannot be used or cannot continue to be used for any reason. Finally, take the time to debrief at the conclusion of enrollment or after the trial has ended to identify problems and areas for improvement on the next trial.